Natrelle Inspira SoftTouch Breast Implants SSF-560Recalls & reported problems
Allergan, Inc. · Natrelle Inspira SSF 560cc Full profile |smooth|round|silicone · Class 3 · Implant
All models of Natrelle Breast Implants (1167) · Natrelle Inspira SoftTouch Breast Implants (195)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Allergan Natrelle Inspira SoftTouch breast implant is a silicone gel implant used in breast augmentation. Most of the 179 reports describe hardened scar tissue around the implant, and some describe ruptures and implants being removed. The reports include 175 injuries, 4 malfunctions and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 175
- Deaths reported
- 0
- Injuries reported
- 171
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 175 adverse event reports that list this exact device (DI 10888628033207), received between May 14, 2019 and Sep 28, 2026 — classified as 171 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (105 reports).
4 other recalls cover devices cleared under the same FDA submission (P020056); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device Appears to Trigger Rejection105
- Material Rupture26
- Patient-Device Incompatibility24
- Adverse Event Without Identified Device or Use Problem13
- Malposition of Device6
- Delivered as Unsterile Product2
- Difficult to Open or Remove Packaging Material2
- Break1
Patient problems
- Capsular Contracture127
- Failure of Implant24
- Unspecified Infection10
- No Clinical Signs, Symptoms or Conditions6
- Seroma4
- Cellulitis3
- No Patient Involvement2
- Bacterial Infection1
Recent adverse event reports
The 25 most recent of 175 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Healthcare professional reported: "hematoma". This record is for the left-side device. The device was explanted.
Patient problems: Hematoma
MAUDE report 50917947 ↗InjurySep 24, 2026Device Appears to Trigger Rejection
Healthcare professional reported "capsular contracture Baker grade III". This record is for the left side. Device remains implanted. Patient was prescribed Singulair.
Patient problems: Capsular Contracture
MAUDE report 50885641 ↗InjurySep 9, 2026Device Appears to Trigger Rejection
Healthcare Professional reported "Capsular Contracture Baker grade IV". This record is for the left side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50682403 ↗InjuryAug 7, 2026Device Appears to Trigger Rejection
Healthcare professional reported "Capsular contracture" Baker Grade III. This record is for the right side. Device remains implanted.
Patient problems: Capsular Contracture
MAUDE report 50169196 ↗InjuryAug 4, 2026Adverse Event Without Identified Device or Use Problem
Healthcare professional reported "previous infection/infection". This record is for the left side. Device was explanted.
Patient problems: Bacterial Infection
MAUDE report 50132155 ↗InjuryJul 9, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED OF THE LEFT SIDE DEVICE: BAKER GRADE IV CAPSULAR CONTRACTURE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25762240 ↗InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED "CELLULITIS". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Cellulitis
MAUDE report 25455108 ↗InjuryJun 4, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 25399852 ↗InjuryJun 3, 2026Malposition of Device
HEALTHCARE PROFESSIONAL REPORTED "IMPLANT FLIPPED". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE HAS BEEN EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25385757 ↗InjuryApr 29, 2026Malposition of Device
HEALTHCARE PROFESSIONAL REPORTED THAT THE ¿IMPLANTS FLIPPED¿. THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 25037236 ↗InjuryApr 9, 2026Malposition of Device
HEALTHCARE PROFESSIONAL REPORTED "MALPOSITION OF IMPLANT AND INTERNAL GEL FRACTURE OF IMPLANT". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24830957 ↗InjuryApr 7, 2026Malposition of Device
HEALTHCARE PROFESSIONAL REPORTED "MALPOSITION OF IMPLANT AND INTERNAL GEL FRACTURE OF IMPLANT". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24811774 ↗InjuryMar 13, 2026Device Appears to Trigger Rejection
PATIENT REPORT "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN". THIS RECORD IS FOR UNKNOWN SIDE. DEVICES REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24595902 ↗InjuryMar 10, 2026Device Appears to Trigger Rejection
PATIENT REPORT "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN". THIS RECORD IS FOR UNKNOWN SIDE. DEVICES REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24556268 ↗InjuryJan 30, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". TREATMENT WAS SINGULAIR. THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24228504 ↗MalfunctionJan 23, 2026Difficult to Open or Remove Packaging Material
SALES REPRESENTATIVE REPORTED ON BEHALF OF HEALTHCARE PROFESSIONAL, "DAMAGED IMPLANT CONTAINER. THE INNER PACKAGING TORE AWAY WHEN OPENING AND THEY HAD TO DISCARD THE ENTIRE IMPLANT". DEVICE WAS NOT IMPLANTED. SURGERY WAS COMPLETED WITH A BACKUP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24169838 ↗InjuryJan 13, 2026Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CONTRACTURE". LATER HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 24063335 ↗InjuryDec 29, 2025Malposition of Device; Migration; Malposition of Device; Migration
HEALTHCARE PROFESSIONAL REPORTED THROUGH NATIONAL BREAST IMPLANT REGISTRY "DEVICE MIGRATION/IMPLANT MALPOSITION, CORRECTION OF ASYMMETRY, CHANGE SHAPE/SIZE/STYLE". THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED, REPLACED AND IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23905111 ↗InjuryNov 12, 2025Malposition of Device; Malposition of Device
HEALTHCARE PROFESSIONAL REPORTED THROUGH DEVICE TRACKING "MALPOSITION". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE WAS EXPLANTED, REPLACED AND WILL NOT BE RETURNED.
Patient problems: Failure of Implant
MAUDE report 23535945 ↗InjuryOct 27, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Patient problems: Capsular Contracture
MAUDE report 23393524 ↗InjuryJul 31, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURE BAKER GRADE III". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22678627 ↗InjuryJul 21, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22559885 ↗InjuryJul 17, 2025Material Rupture; Material Rupture
PATIENT REPORTED LEFT SIDE RUPTURE AND PAINFUL. THE DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22530381 ↗InjuryJul 11, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. DEVICE WAS EXPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22484557 ↗InjuryJul 2, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE REMAINS IMPLANTED.
Patient problems: Capsular Contracture
MAUDE report 22383188 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P020056. One submission often covers many models, so check the product and lot details in each record.
- Z-0700-2020 · Nov 6, 2019 · TerminatedNatrelle Silicone Filled Breast Implants for the following Styles and Sizes: Style 10, Style 15, Style 20, Style 40, Style 45 Style 10/UDI: NATRELLE Style 10-180 Gel Round Mod
- Z-0701-2020 · Nov 6, 2019 · TerminatedNatrelle Inspira Sillicone-Filled Breast Implants for the following Styles and Sizes: 7607 SSM, 7608 SSF, 7609 SSX, 7513 SRL, 7514 SRLP, 7515 SRM, 7516 SRF, 7517 SRX, 7626 SCL, 762
- Z-2454-2019 · Jul 24, 2019 · Open, ClassifiedNatrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate Profile, Sterile, for the following style numbers: Style 110:110-090, 110-120, 110-150, 110-180, 110-
- Z-2453-2019 · Jul 24, 2019 · Open, ClassifiedNatrelle Inspira, Silicone-Filled Breast Implants, Sterile, for the following style numbers: Style TRL: TRL-110TRL-125,TRL-140,TRL-170,TRL-200,TRL-230,TRL-260,TRL-290,TRL-320,TR
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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